Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2025-12-25 @ 8:18 PM
Study NCT ID:
NCT00026169
Status:
COMPLETED
Last Update Posted:
2013-01-10
First Post:
2001-11-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Imatinib Mesylate in Treating Patients With Advanced Cancer and Kidney Failure
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
A Phase I Pharmacokinetic Study of STI571 in Patients With Advanced Malignancies and Varying Degrees of Renal Dysfunction for the CTEP-Sponsored Organ Dysfunction Working Group
Status:
COMPLETED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Phase I trial to determine the dose of imatinib mesylate that is most effective with the least amount of toxic side effects in treating patients who have advanced cancer and kidney failure. Imatinib mesylate may stop the growth of cancer cells by stopping the enzyme necessary for cancer cell growth. Kidney failure may delay the elimination of imatinib mesylate from the body, which may lead to longer drug exposure and increase toxic side effects
Detailed Description:
PRIMARY OBJECTIVES:
I. To establish the maximum tolerated dose (MTD) of STI571 for cohorts of patients with varying degrees of renal dysfunction (normal, mild, moderate, and severe).
II. To determine the effects of renal dysfunction on the plasma pharmacokinetics and pharmacodynamics of STI571.
III. To evaluate the safety of STI571 in patients with various degrees of renal dysfunction.
OUTLINE: This is a dose-escalation study. Patients are stratified according to creatinine clearance (at least 60 mL/min vs 40-59 mL/min vs 20-39 mL/min vs less than 20 mL/min vs any creatinine clearance and undergoing dialysis).
Patients receive oral imatinib mesylate once or twice daily on days 1 and 4-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients in each stratum receive escalating doses of imatinib mesylate until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: Approximately 60-69 patients (about 12 per stratum) will be accrued for this study.
I. To establish the maximum tolerated dose (MTD) of STI571 for cohorts of patients with varying degrees of renal dysfunction (normal, mild, moderate, and severe).
II. To determine the effects of renal dysfunction on the plasma pharmacokinetics and pharmacodynamics of STI571.
III. To evaluate the safety of STI571 in patients with various degrees of renal dysfunction.
OUTLINE: This is a dose-escalation study. Patients are stratified according to creatinine clearance (at least 60 mL/min vs 40-59 mL/min vs 20-39 mL/min vs less than 20 mL/min vs any creatinine clearance and undergoing dialysis).
Patients receive oral imatinib mesylate once or twice daily on days 1 and 4-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients in each stratum receive escalating doses of imatinib mesylate until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: Approximately 60-69 patients (about 12 per stratum) will be accrued for this study.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| CWRU 1Y01 | None | None | View | |
| U01CA062487 | NIH | None | https://reporter.nih.gov/quic… | View |
| U01CA062505 | NIH | None | https://reporter.nih.gov/quic… | View |
| U01CA069853 | NIH | None | https://reporter.nih.gov/quic… | View |
| U01CA062502 | NIH | None | https://reporter.nih.gov/quic… | View |
| U01CA062491 | NIH | None | https://reporter.nih.gov/quic… | View |
| U01CA099168 | NIH | None | https://reporter.nih.gov/quic… | View |